Also known as DreamStation BiPAP autoSV, Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T, Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced, Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series). Patient safety is our top priority, and we are committed to supporting our patients, durable medical equipment providers (DMEs), distributors, home health partners, and clinicians through the complete correction process. Updating everyone on what they need to know and do, and to participate in the corrective action. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). You can also upload your proof of purchase, so you have it, if you need it for service or repairs. The following updates in relation to device testing have been released by Philips RS North America on this webpage: Please note that the Philips RS North America website also contains information specific to the CPAP, BiPAP and mechanical ventilator device recall in the USA, which may be different to and not relevant for Australia. As part of the notification process, customers and patients will be provided with more information on the next steps to implement the solution as it becomes available. Patient safety is our top priority, and we are committed to supporting our . Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non- Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device's air Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Will existing patient devices that fail be replaced? Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . Are you still taking new orders for affected products? Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. Once you receive your replacement device, you will need to return your old device. The letter offered the following recommendations. All patients who register their details will be provided with regular updates. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers. Following Philips public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. All rights reserved. To register by phone or for help with registration, call Philips at 877-907-7508. Where do I direct questions about my replacement device? 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. When you receive your replacement device, in the box you will find instructions on how to set up your replacement device and return your old device. 3. If you have not done so already, please click here to begin the device registration process. All rights reserved. The new material will also replace the current sound abatement foam in future products. Before you send back your old device to Philips, please make sure that you remove and keep your current accessories (including your carry bag, mask, tubing, humidifier, battery, modem and SD card if applicable) as they may be used with your replacement device. If you have a secondary back up device, switch over to that device. All rights reserved. This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia or 0800 578 297 in New Zealand. The affected products are identified in the tables below: A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected by the corrective action may have different sound abatement foam material, as new materials and technologies have become available over time. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? Customers who need any further information or support should contact Philips Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. No further products are affected by this issue. Talk with health care providers to decide if your care and treatment should change as a result of this recall. Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. Plaintiffsfiled a Second Amended Complaint in November 2022. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. December 2, 2021 (latest update) . See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. The complaints variously allege economic loss,personal injury and, in some cases, the need for medical monitoringrelated to devices subject to the Philips Respironics recall In the United States, as of January 2023,putative economic loss and medical monitoring class actions andapproximately 320 personal injury lawsuits have been consolidated into amultidistrict litigation (MDL) in Pennsylvania and are currently pending In September 2022, the MDL court establisheda voluntary, court-approved census registry, and associated tolling, forpotential claimants who have not filed claims, but may file claims in thefuture, relating to the recalled devices. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. We thank you for your patience as we work to restore your trust. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. The new material will also replace the current sound abatement foam in future products. Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution. This Alert was related only to Trilogy 100 ventilators that were repaired. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto CPAP unit. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. Click here to view a Notice from the Federal Court of Australia advising Group Members of the proposed discontinuance of a class action commenced by Mr Peter Lewis, represented by Carbone Lawyers, against Philips in relation to certain CPAP, Bi-PAP and mechanical ventilators. Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand will advise patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: For patients using life-sustaining mechanical ventilator devices: The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, Philips recommends that devices are replaced after five years of use. Patients who are concerned should check to see if their device is affected by the corrective action. The company has developed a comprehensive plan for this correction, and has already begun this process. As a first step, if your device is affected, please start the. When you receive your replacement device, in the box you will find instructions on how to set up your replacement device and return your old device. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Philips Sleep and respiratory care. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click, Philips Respironics continues to engage with the US Food and Drug Administration (FDA)on the steps it has taken in response to the FDAs Form 483 observations, Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issueson a forward-going basis, In addition, on April 8, 2022, Philips Respironics and certain of Philips subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall. Can Philips replace products under warranty or repair devices under warranty? Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. 1800-28-63-020. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. Begin registration process 877-907-7508 News and Updates > Important update to Philips US recall notification Important update to Philips US recall notification November 16, 2021 Philips has updated the US recall notification to align with the FDA's recommendation in connection with these recalls and provide broader guidance on use. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. 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